Archive for the ‘Medicine’ Category

Monday, July 3rd, 2017

Photo: linkedin.com

Martin Shkreli is on trial for federal securities fraud, but regardless of how the judge instructs the jury to forget his arrogance in another high profile example of greed, it may nevertheless impact his destiny. Well over 100 potential jurors were already excused because they had nasty things to say about the man.

Photo: drugs.com

I previously wrote about Shkreli in “Service of Side Effects of Drug Prices.” He earned the rights to a life-saving drug, Daraprim, that for decades saved lives of those with a potentially fatal parasitic infection, when he bought a drug company, Turing Pharmaceuticals AG. He raised the price of a pill to $750 from $13.50 because, as Wall Street Journal reporter Rebecca Davis O’Brien quoted him, “he had an obligation to ‘maximize our profit.’”

Heather Bresch, CEO of Mylan, led the charge on the price of the emergency allergy medicine from $94 for a pair when her company purchased the product, to $700, for those without insurance, or $630 with. Further, the pens need to be replaced every year. Under pressure, the company subsequently introduced a generic version that cost $225-$425 wrote Linda A. Johnson, ABC News.

“Analysts and others have estimated that it costs less than $20 to produce a pair of EpiPens,” she reported.

This was background to the real focus of Johnson’s news: The FDA “approved Adamis Pharmaceuticals Corp.’s product, which should go on sale later this year. Symjepi is a syringe prefilled with the hormone epinephrine, which helps stop life-threatening allergic reactions from insect stings and bites, foods such as nuts and eggs, or certain medications.”

She continued: “Adamis spokesman Mark Flather said Symjepi is intended to be a “low-cost alternative” to EpiPen and similar products, and the company is aiming to sell it for less than generic EpiPens.” Claims about Symjepi range from being easier to use than EpiPen and because the syringe is smaller, it fits more easily in pockets and handbags.

Here’s hoping Symjepi [what a name] will represent healthy competition to EpiPen, serving to adjust the prices of all antidotes to severe allergies. “Adamis said it is still lining up a distributor so it hasn’t set the exact price for its product, which will be sold in pairs like EpiPen,” wrote Johnson.

I believe in profits but really.

How can a manufacturer of life-saving medicines gouge to such an extent and sleep at night?

How can investors stand silent?

Is this approach standard practice with pharmaceuticals?

Are there any benevolent CEOs?

Are these manufacturers encouraged by the climate in which 217 House members and at least 43 Senators don’t blink at tossing 22 million off health insurance while lowering taxes for the wealthy?

And last, public pressure has put an end to careers of corporate and religious sexual abusers and loudmouth public figures who use inappropriate language. Will it impact flagrant examples of corporate greed?

Monday, June 26th, 2017

Photo: history.com

The California law suit against Bristol-Myers Squibb and the blood thinner Plavix involved almost 700 plaintiffs because the drug “allegedly created a substantial risk of heart attack, stroke and other injuries,” wrote Jess Bravin in The Wall Street Journal. But only 86 plaintiffs were from California and according to a new Supreme Court 8-1 ruling, only those cases can be heard in that state. Justice Sonia Sotomayor dissented.

Photo: drugsdb.com

“The ruling was one of a series this term limiting so-called forum shopping, where plaintiffs’ attorneys file suit in a state or federal court they believe will be sympathetic to their claims,” Bravin reported.

California’s Supreme Court argued that all should be considered because the claims were similar; Bristol-Myers Squibb sales reached $900+million in the state and the drug was sold around the country. Justice Sotomayor wrote: “There is nothing unfair about subjecting a massive corporation to suit in a state for a nationwide course of conduct that injures both forum residents and nonresidents alike.”

The winning argument went that “Companies have long complained that plaintiffs in certain cases seek out venues where they believe they are most likely to receive favorable rulings, even when the cases involved may have only a tenuous connection to the area.”

Supreme Court Justice Sonia Sotomayor. Photo: biography.com

According to Bravin, Justice Samuel Alito wrote: “The nonresidents were not prescribed Plavix in California, did not purchase Plavix in California, did not ingest Plavix in California, and were not injured by Plavix in California. The mere fact that other plaintiffs were prescribed, obtained, and ingested Plavix in California—and allegedly sustained the same injuries as did the nonresidents—does not allow the state to assert specific jurisdiction over the nonresidents’ claims.”

Bravin added: “Consumers groups, however, have warned that cutting back too sharply on plaintiffs’ ability to sue could give big companies more ways to avoid responsibility for harm they cause.”

Had you heard of forum-shopping before? Do you agree with the Supreme Court—that the court in a state can hear only about plaintiffs from that state? Or does that help corporations “avoid responsibility for harm they cause,” that consumer groups fear?

Monday, April 17th, 2017

Most of my friends and colleagues present themselves for medical tests and checkups when they should while I drag my feet attending to only the most essential. My philosophy: Who wants to know?

So it would be very unlikely for me to send away to 23andMe at any time in my life to learn whether one or more of the 10 diseases the company tests for, such as late-onset Alzheimer’s or Parkinson’s, will afflict me.

There are many chomping at the bit to find out and now the FDA says that they can: No more need to pass by a genetic counselor or through a doctor for the privilege. Spit into a receptacle to provide a sample of saliva; send $199 and voila—you’ll soon know about how or if you relate to any of the 10.

Jessica Boddy, NPR summarized info on an FDA press release: “The tests assess genetic risk for the conditions but don’t diagnose them, the FDA says. The agency urges consumers to use their results to ‘help to make decisions about lifestyle choices or to inform discussions with a health care professional.’”

The FDA’s Center for Devices and Radiological Health director Jeffrey Shuren said “‘it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.’ Other known factors that can play into the development of disease include diet, environment and tobacco use.”

Photo: thefactfile.org

We already know about the importance of a healthy diet and the risks of tobacco use as they relate to all sorts of diseases–so nothing new here–and I can’t do much about my environment. Loosening regulations on power plants and reducing fuel efficiency standards for cars is going to impact everyone in a bad way. I wonder if people in 45’s administration realize that they, their children and grandchildren might suffer as a result?

Referring to test results Boddy quoted a Harvard Medical School professor who warned that the “information is complicated.”

Nobody in the article spoke up for those who don’t want to know. Do you want to learn what your genetic makeup indicates might happen? Would you be irritated if at 68 you sold your house and all your belongings to move into an adult care facility and found yourself at 95 in great form still with no signs of late-onset Alzheimer’s? Would knowing spoil what’s left of your life be it 20 or 70 years? Would you cancel your marriage plans if you wanted to have children and you learned that both you and your intended had similar genetic indicators for a nasty disease?

Thursday, April 7th, 2016

The new law in New York State that makes it mandatory for physicians to order drugs electronically immediately made me think of a few things.

I worked in an office where if one person chronically left open a window midwinter potentially causing frozen pipes and other calamities or did some other thing management frowned upon, everyone got a memo—not just the offender. The alleged major reason for ordering prescriptions online is to cut down on doctor shopping for pain killers like Vicodin or Percocet. So why make doctors go through the rigmarole for all prescriptions?

An ace editor reporting on product introductions in a trade magazine mistyped one digit in a client’s toll free number, [prior to websites]. Readers calling the number got an earful of porn. We laughed, she was embarrassed, errors happen when you juggle work and are rushed. I predict that when a doctor types a bunch of digits while listening to a patient’s complaints and questions he/she either won’t hear important information or is set up to make mistakes in the order.

Say you’re the receptionist tasked with the pill ordering chore. As you take messages, make appointments, greet patients and mishear the name of the drug the boss yelled in from another room, do you think you’ll get right all the codes for meds and pharmacies? What the patient gets may be a surprise.

I feel that the more personal information we are forced to put in easily hackable places the worse for all. In a recent comment about a previous post “hb” wrote: “Given that the internet is now totally insecure as to confidentiality… if you catch syphilis cavorting with a prostitute, not just your wife/husband and children/parents, but also all your friends and neighbors are going to know about it within weeks. Maybe the young just don’t care, but I do!” My thoughts precisely.

I heard Jon LaPook, MD, chief medical correspondent for CBS News with Holly Phillips, MD, [Photos, Left], on the “Morning Rounds” segment of CBS This Morning Saturday on April 2. Dr. Phillips admitted it’s faster for her to call in a prescription and doesn’t think the electronic logon and pharmacy search is time-effective but she seemed resigned as all NY docs must be. If they don’t comply, they are subject to fines, loss of license—even jail time.

Dr. LaPook said he loved the system. A patient contacted him while he was on a flight and he was able to submit a prescription from the plane. However, the only additional benefit he could point to, in addition to controlling access to painkillers, was that there will be no mistakes made by bad handwriting where the pharmacist “reads quinine when the doctor meant Quinidine.” He admitted that the checking part of the process—to confirm that the patient isn’t getting painkillers elsewhere–is clunky but predicted that the system will eventually be great.

A young friend, who can fix any computer and is more tech-savvy than most, told me that the only winners in this new arrangement are the people who sold the programs to physicians and pharmacies. Do you agree?

Monday, October 19th, 2015

I read about the fallout of dodgy if legal pricing practices by big pharma from three viewpoints in recent weeks causing both curious and predictable side effects.

James Surowiecki wrote “Taking on the Drug Profiteers,” in The New Yorker, about the infamous Martin Shkreli and concluded that the problem with Shkreli’s exploiting loopholes in the pricing of drugs is “not with the man but the system that has let him thrive.” Shkreli, who owns Turin Pharmaceuticals, raised the price of Daraprim from $13.50 to $750 a pill because he could. This is “rent seeking,” that Surowiecki defined as “increasing profits not by adding real value for customers but by exploiting loopholes.” Daraprim, first sold in 1953, treats toxoplasmosis. After public uproar Shkreli lowered the price of the drug that among other things treats AIDS and malaria.

It’s not the only example of the rent-seeking model, he wrote, adding to the list Thiola, to treat kidney disease. The company that makes it is also owned by Shkreli. Last year the price increased “twenty fold.” A company called K-V Pharmaceutical increased the price for a shot that thwarts preterm births from $15 to $1,500. “There have also been alarming increases in the pries of common drugs like doxycyclene. Generic-drug makers have been merging with each other, leaving fewer competitors.”

Innocent people who are sick aren’t the only victims according to Michelle Celarier’s article, “Stuck in the Mud,” in the New York Post last week. She wrote about battered portfolios of some “hotshot hedge fund activists” and big pharma accounted for one of the headaches. She reported Bill Ackman of Pershing Fund’s “5.7 percent stake in Canadian pharmaceutical giant Valeant, which announced late Wednesday that it is under investigation by federal prosecutors in New York and Massachusetts regarding pricing of drugs,” as one of the problems. “Valeant has lost 36 percent of its value since Aug. 1.” Pershing Fund is down $600 million as a result.

The Wall Street Journal dug a bit deeper into drug pricing. In “Valeant Probe Reprises Focus on Drug Pricing,” Jonathan D. Rockoff reported that pharmaceutical companies paid $3 billion + in fines in the last 10 years “to resolve pricing cases.” I can hear Jackie Gleason in his role in the “Honeymooners” referring to “a mere bag of shells.” According to Google, the global industry represents $300 billion a year.

The fines are largely due to overcharges to Medicare and Medicaid. According to the law, a company must offer Medicaid its best rate. Merck didn’t do that.with Zocor–a cholesterol lowering drug and a painkiller no longer on the market, Vioxx. Merck settled at $650 million. [But how much did it make?] Rockoff listed other examples in the past but you get the idea. Pfizer’s Wyeth division is currently being investigated for overcharging Medicaid for heartburn medicine Protonix.

That’s not all. Big pharma gives money to charities that in turn pay for the prescriptions of needy patients. Valeant spent $544 million in 2014 and anticipates $630 million this year. That’s legal. What’s not is when the charity directs the patient to a certain drug. That’s considered a kickback. Let’s get real: Who wouldn’t promote the products of a company that supports your charity/your job?

What do you think of a corporate model that takes advantage of loopholes to raise prices dramatically to make money to the detriment of its often desperate customers? Do you think relatively tiny fees act as the slightest deterrent to a corporation intent on making a profit by skirting the law? What about Valeant giving $millions to charity that comes back in business for its products?

If you or a loved one has a heart condition, don’t click away just yet: Reporter Andrew Pollack noted that cardiology societies are following in oncologists’ footsteps. And I wouldn’t be surprised if this trend soon affects patients with any and all conditions if it effectively cuts costs for insurers.

Actor Robert Young playing Marcus Welby, MD

Pollack wrote “Roche’s Avastin, when added to chemotherapy, had a net health benefit of 16 out of 130 possible points when used as an initial treatment for advanced lung cancer. Its monthly cost was $11,907.87, compared to $182.09 for the chemotherapy alone.

“Eli Lilly’s Alimta for that same use had a net health benefit of zero with a cost exceeding $9,000 a month compared to about $800 a month for the drugs it was compared to in the clinical trial.”

Later in the article Pollack spelled out the rating system: “Drugs for advanced cancer are given a score from 0 to 130. Up to 80 of the points are based on a drug’s effectiveness in prolonging lives, delaying the worsening of cancer or shrinking tumors. Then up to 20 points can be added or subtracted based on side effects. And up to 30 bonus points can be granted if the drug relieves cancer symptoms or allows a patient to go without treatment for a period of time.”

Actor Hugh Laurie who plays Dr. House

Regardless of cost why would anyone prescribe a drug that benefits a patient from zero to 16 “points” out of 130?

Other news that was unsettling: “The release by the American Society of Clinical Oncology of what it calls its ‘value framework,’ is part of a change in thinking among doctors, who once largely chose drugs based on their medical attributes alone.” [The underline is mine.] Silly me: and I thought doctors still prescribe what they do according to how a drug helps a patient.

According to Pollack the average cost of cancer drugs runs $10,000/month and some as much as $30,000/month. This is information, Dr. Richard Schilsky said at a news conference, that some doctors don’t know nor do patients. Schilsky is chief medical officer of the American Society of Clinical Oncology. [Why is this significant? Even if you’ve been paying for health insurance for eons and have hardly used a cent until you need to, you can reach the ceiling when off goes the insurance spigot.]

Pollack wrote that this value framework considers the cost to the patient and the health system. I assume “health system” translates to government supported Medicare and Medicaid plans.

Ingrid Bergman playing Dr. Constance Petersen

As a result, Pollack observed, doctors are now put in the role of “being stewards of societal resources.” He continued, “That is somewhat of a controversial role for doctors, since it might conflict with their duty to the patient in front of them. But the oncology society said it did not see those roles as being in conflict.”

Other points Pollack made include:

A rep for the Pharmaceutical Research and Manufacturers of America said the cost of drugs represents only 20 percent of treatment.

The cost of drugs is unrelated to how “novel it is or whether it prolonged life versus just shrinking tumors.”

In Britain, a drug is rated according to its “cost per extra year of life they provide adjusted by side effects and symptoms.”

Starting in June United Healthcare requires “oncologists to get prior approval from the insurance company for every cancer drug they administer. The company will then track what happens to patients and eventually provide information to doctors about how well each drug works.”

Summarizing the questions:

Why prescribe a drug that does little if anything to better a patient’s health or length of life?

Is a doctor who chooses a drug for a patient based solely on its medical attributes old fashioned and out of step and will he/she soon be forced out of work by insurance companies?

If a patient can scrape together the co-pay of a super expensive drug, can an insurance company refuse to pay its part? Then what?

Will United Healthcare only use its approval to track drug effectiveness, as Pollack suggests, or eventually will it control costs by refusing to pay?

Is the American Society of Clinical Oncology correct when it asserts that there is no conflict for doctors who are now made responsible for the country’s medical resources and their responsibility to their patients?

Unless people have unlimited incomes, most adults are aware of what they pay for food, beverages, clothing, shelter and only recently have they become aware of the cost of healthcare. Isn’t this a good thing?

Thursday, April 30th, 2015

J. McCarthy, who posted a comment on my recent post, “Service of Little If Any Assistance: Physician Admin Staffs Fall Down on the Job,” followed up a few days ago with another relevant comment describing medical care that he had just received from several doctors and their staffs. It warranted a post of its own, not just to present a fresh perspective on medical care, but also because the woman who wrote the previous post made the most distressing point about how horribly she had been treated by several of her doctors and their administrative staffs.

He wrote:

I’m referring to my previous advice, “Do what a specialist with a national reputation told me to do. ‘If you want to get a good doctor, get an old doctor.’ Old doctors tend to have competent staffs.” The following story about what led up to the unsolicited, unexpected phone call my ophthalmologist’s most solicitous, crack, long-time nurse just made to me, might be of interest to your readers.

On a visit for my routine annual eye checkup, I told the ophthalmologist about something strange that had happened recently with one of my eyes. He took it seriously and gave me an even more extensive examination than usual. After it, he told me that there was nothing wrong with my eyes, but that he suspected I might have a circulation problem. He asked me if I still was seeing my longtime cardiologist who coincidentally is his patient as well. I said yes, and he picked up the telephone and called him.

Three days later, I was in the cardiologist’s office. We go back 30 years, and even though he practically has my heart memorized by now, he thoroughly examined me. (He took my blood himself as he always does.) Next, he had his nurse, who has been with him since he opened his practice, hook me up to a bunch of machines and do a series of heart tests. I’ve known her as long as him, and trust her absolutely.

The next day, the doctor called to tell me that the tests had turned up nothing new and that, as far as he could tell, I did not have a circulation problem. Then, he gave me two choices: Either I could see more specialists and take more tests to double check, or I could do nothing and see what happened. I chose to do nothing. My doctor agreed and said that he would follow up with our ophthalmologist. I was satisfied and thought that was the end of it, but it was not.

What did theophthalmologist’s nurse call me about? Her boss wanted me to know that he fully concurred with thecardiologist’s and my decision. That was a call that did not have to be made. It was going the “extra mile.”

Incidentally, both doctors accept insurance and are all well over 65. Their nurses both have been with them at least 20 years.

Have you heard of doctors who collaborate with each other and their nurses in this way? Or is medicine more like Washington where the executive and legislative branches clash, and our senators and congressmen and women don’t cooperate with each other? Do you have examples of medical admins in today’s “rush-rush” climate who make your day rather than ruin it?

Monday, February 9th, 2015

The previous post covered wine, this one medical treatment.

What a Pill

“When patients with Parkinson’s disease received an injection described as an effective drug costing $1,500 per dose, their motor function improved significantly more than when they got one supposedly costing $100, scientists reported,” wrote Sharon Begley in “Expensive’ placebo beats ‘cheap’ one in Parkinson’s disease” on reuters.com.

“Underlining the power of expectations, the motor improvements, measured by a standard Parkinson’s assessment, occurred even though both injections contained only saline and no active ingredients.

“The research, said an editorial in the journal Neurology, which published it, ‘takes the study of placebo effect to a new dimension.'”

Of the dozen volunteers in the study, observed neurologist Alberto Espay, the greatest improvement happened for the eight who expected the expensive drug to be more effective. The other four, who didn’t anticipate benefits, showed little change, wrote Espay, University of Cincinnati, who led the study.

In your experience, what part of a successful treatment for illness involved the mind and what the medicine? If you pay a lot for a drug, treatment or physician, are you more confident that the results will be positive?

Thursday, January 8th, 2015

I would like to know how you gauge which commercials to trust, especially those involving health-related products, identity theft protection, tax relief advice, weight loss, gardening aids, deer and mouse repellants.

I was inspired to cover the topic [again] after listening to a segment of “Health Matters,” on NPR sponsored by Sharon Hospital in Conn. The doctor, Jared Zelman, shared sage if obvious advice: Don’t believe quick fix solutions regarding weight loss remedies or those described by people who claim to have been cured of their chronic diseases simply by taking X. The hospital and/or doctor must come across plenty who fall for useless tonics or they wouldn’t select the topic–there are so many other potential ones.

Radio personalities tout [and say they swear by] miracle anti-wrinkle creams, weight loss tonics that take off 30-40 lbs. in a month, easy back tax relief for those who owe $10K or more, foolproof rodent repellants, effective organic garden pest deterrents and protection from identity theft. The latter makes me chuckle: If Sony, Target, TJ Maxx and Home Depot can’t fend off hackers while allegedly spending $billions, how are Mr. and Mrs. Middle America supposed to protect themselves by tossing monthly dollars at some company?

If I’d saved what I’ve spent on useless mouse and deer repellants alone I’d be on easy street. I continue to fall for what I so desperately wish would work. Do you? And as I asked in the lead, how do you know what is really effective? Are you ever tempted to give something new a chance?

Thursday, March 7th, 2013

With all the technology at our fingertips, I wonder how well we have learned to effectively communicate, absorb and act on information, especially in giant organizations and companies.

Oh what a tangled web we weave….

I buy a 10-trip web ticket on the Internet—have been doing so for years. When I handed mine to the conductor, she said, “It’s expired.” I said, “I just got it in the mail!” She pointed to a date on the ticket which must have been the date the ticket was processed. She took it as the date the ticket expires. I explained the situation and convincingly as she didn’t make me pay, but the confrontation was heated and I didn’t like all the fuss.

The next conductor punched my ticket without a word so I asked him what the deal was and he said that scads of tickets were mailed with the distribution rather than the expiration date and not to worry about it—the conductors all received a directive about the glitch.

The ticket-collecting conductor for my third ride on the web ticket had not read the directive as I had to again explain the situation, with pairs of rider’s eyes staring at me suspiciously from behind Kindles and newspapers as I argued for my cause.

So it got me to ponder how, when you run something as big as Metro-North and there’s a mistake like this one, a company gets out the word effectively.

Metro-North has the email addresses of all the web ticket buyers. Why not send a copy of the directive to carry in our wallets at minimal cost in time and none in out of pocket.

Sticker shock

I thought of this when a friend told me about the letter she received from the New York State Department of Motor Vehicles. It explained that the department “has identified a defect in the registration documents supplied by our vendor that has prevented the printing of most registrations and window stickers that were ordered starting January 1.”

The letter went on to say that her registration is processed and everything is in order and if kept in the vehicle, the letter should serve as proof should she need to show it to law enforcement officials. Further, all police agencies and courts were notified.

Since then, she got the sticker. In the interim, this friend, who lives in Westchester, had received no summons for an expired registration.

The police and traffic staff in NYC have an easier time checking registration dates on parked cars in city streets to fulfill their ticket quota and I wonder: Did they all get and retain the message? Recipients of the letter wouldn’t put it in their car windows because both name and address are clearly typed in a bigger font than the body of the letter. My parents, parked on a city street, once got a ticket for being one day overdue.

Drug test

I renewed a prescription on the phone via press one press two, punch in your Rx number, for an ordinary drug from a store that asks you for the date and time you expect to pick up your order. When I got there an hour or two after the time I’d noted, the pharmacy attendant said that the meds were on back order and asked if I could return the next day. The next day I got a call to tell me my prescription was waiting for me.

To save me a fruitless trip, shouldn’t they have also called to tell me when it wasn’t?

Are my expectations too high? Do you have examples where someone didn’t get the message and instances of a company or organization communicating them flawlessly, where everyone involved heard and remembered?